Suture passer

ABSTRACT

A suturing device for grasping soft tissue and placing stitches in soft tissue during endoscopic procedures is described. An elongate housing with a stationary jaw and a movable jaw disposed at the distal end are configured for grasping and releasing soft tissue. A movable needle disposed within the housing is actuated to engage a length of suture and drive the suture into and through the grasped soft tissue. A suture capture member is disposed on the movable jaw and is configured to allow passage of the needle therethrough while securing a portion of the stitched length of suture.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.12/619,124, filed Nov. 16, 2009, now U.S. Pat. No. 9,211,118 issued Dec.15, 2015, which is incorporated by reference herein.

FIELD OF THE DISCLOSURE

The present invention relates to a method and apparatus for placingsutures in soft tissue. More particularly, the present invention relatesto apparatus and methods improve the ability to place a stitch or suturedeeper within tissue when compared to conventional methods. Althoughmethods and devices described herein make reference to arthroscopicrepair of torn rotator cuffs, the principles of the devices and methodsmay be applied to any soft tissue application.

BACKGROUND

Traditional suturing of body tissues is a time consuming aspect of mostsurgical procedures. Many surgical procedures are currently beingperformed where it is necessary to make a large opening to expose thearea of, for instance, the human body that requires surgical repair. Inrecent practice, endoscopes are used to allow the viewing of certainareas of the body through a small puncture wound without exposing theentire body cavity. Endoscopes can be used in conjunction withspecialized surgical instrumentation to detect, diagnose, and repairareas of the body that were previously only able to be repaired usingtraditional “open” surgery. In conjunction with the advances inendoscopic surgery, there have been many attempts to simplify the taskof driving a needle carrying suture through body tissues to approximate,ligate and fixate them. Many prior disclosures, such as described inU.S. Pat. No. 919,138 to Drake et al., employs a hollow needle driventhrough the tissue with the suture material passing through the hollowcenter lumen. The needle is withdrawn, leaving the suture material inplace, and the suture is tied, completing the approximation. Alimitation of these types of devices is that they are particularlyadapted for use in open surgical procedures where there is ample roomfor the surgeon to manipulate the instrument.

Others have attempted to devise suturing instruments that resembletraditional forceps, such as U.S. Pat. No. 3,946,740 to Bassett. Thesedevices pinch tissue between opposing jaws and pass a needle from onejaw through the tissue to the other jaw. Graspers then pull the needleand suture material through the tissue. A limitation of these designs isthat they also are adapted primarily for open surgery, in that theyrequire exposure of the tissues to be sutured in order that the tissuemay be grasped or pinched between the jaws of the instrument. This is asevere limitation in the case of endoscopic surgery.

Less invasive arthroscopic techniques are beginning to be developed inan effort to address the shortcomings of open surgical repair. Access tothe operative site using endosurgical or minimally invasive techniquesis accomplished by inserting small tubes, known as trocars, into a bodycavity. These trocars have a diameter of, for example, between 3 mm and30 mm and a length of about 150 mm (6 inches). Working through smalltrocar portals that minimize disruption of the deltoid muscle, surgeonshave been able to reattach the rotator cuff using various bone anchorand suture configurations. The rotator cuff is sutured intracorporeallyusing instruments and techniques such as those previously described. Therepair is completed by tying the cuff down against bone using the anchorand suture that is knotted to secure the tissue in proximity to thebone.

The suture knots in the tissue can be bulky and create a painfulimpingement of the tendon on the bone. This is because the knots end upon top of the cuff, in the sub-acromial space, and have the opportunityto rub on the acromion as the arm is raised. Because non-absorbablesuture materials are used for these types of repairs, the suture andassociated knots are not absorbed into the body, and hence provide aconstant, painful reminder of their presence. Accordingly, devicesconfigured to place, retrieve, and secure sutures in tissue withoutreliance on tying knots are desirable. Additionally, devices configuredto grasp and secure tissue to effect the placement of suture in aparticular location of the tissue provide an advantageous utility thatis valued by practitioners during the practice of endoscopic tissuerepair.

SUMMARY

The present device and methods include an instrument that combines thefunction of both grasping the tissue and passing sutures through thetissue to form a stitch. In a general sense, the instrument includes apair of grasping jaws that oppose each other along a line substantiallyperpendicular to the long axis of the instrument. The distal end of theinstrument incorporates the fixed jaw, and proximal to that jaw is amoveable jaw that is controlled by the user via a lever on the handgrip.

In a preferred embodiment the instrument is inserted through a portalknown as a trocar cannula. The portal is created by first making anincision in the skin, and then inserting a cannula through the incisionto the repair site. The distal end of the instrument is inserted throughthe cannula under direct visualization from a second trocar cannula thathas been previously inserted. The visualization is accomplished via anendoscope, of a type well known in the art. The instrument is inserteduntil the jaws reach, for example, torn rotator cuff tissue. Inoperation, the distal end of the grasper aspect of the instrument ispositioned at the repair site underneath the tissue to be grasped. Themoveable jaw is movable toward the stationary jaw by squeezing thehandle lever. The handle lever moves inward by pivoting about a pivotpin.

Once the surgeon is satisfied with the placement of the grasper on thegrasped tissue, the surgeon can then deploy a suture needle to create astitch in the tissue, for example, the above-mentioned torn rotatorcuff. In operation, the suture needle may be advanced through thegrasped tissues by actuating a second lever. In order to create thesuture, at least one needle advances to engage a suture disposed in thestationary jaw. The needle comprises a distal point, a proximal shaft,and a hook defining a suture holding area. The suture needle is actuatedsuch that the tip of the suture needle engages a portion of suturehoused in a more distal portion of the stationary jaw, and begins topenetrate through the bottom of the grasped tissue and advances upwardtoward the movable jaw. Thereby, the device includes features to allowthe needle engage and capture the suture and then to penetrate tissueand draw the suture through the tissue.

The movable jaw may incorporate a suture capture member disposed at adistal end of the device. In certain embodiments, the suture capturemember may comprise a cartridge removably disposed on one of the jaws atthe distal end of the distal. The suture capture member may becharacterized by apertures coaxial to the longitudinal axis of thesuturing device designed to allow the suture needle engaged with sutureto pass therethrough. The suture capture member comprises componentsdesigned to spring away from the aperture in order to allow passage ofthe suture needle and suture through the aperture on the upstroke of theneedle through the tissue. The aperture may be further characterized byopposed serrated edges, fingers or teeth to assist in securing theportion of suture as the needle begins a down stroke through theaperture and the tissue.

The instrument can be retracted back through the portal via the trocarcannula. As the instrument is removed from the suture site, the freeends of the suture are retrieved as well. This causes the suture form alooped stitch in the tissue.

Thus, the disclosed embodiments comprise a combination of features andcharacteristics which are directed to allow it to overcome variousshortcomings of prior devices. The various characteristics describedabove, as well as other features, will be readily apparent to thoseskilled in the art upon reading the following detailed description ofthe preferred embodiments of the invention, and by referring to theaccompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a perspective view of a suturing device in accordancewith at least some embodiments.

FIG. 2A illustrates a perspective view of a suture capture member inaccordance with at least some embodiments.

FIG. 2B illustrates a cross-sectional view of the suture capture memberin accordance with at least some embodiments.

FIG. 3 illustrates a perspective view of a suture capture cartridge inaccordance with at least some embodiments.

FIG. 4A illustrates a perspective view of a suturing device inaccordance with at least some embodiments.

FIG. 4B illustrates a perspective view of a suturing device inaccordance with at least some embodiments.

FIG. 4C illustrates a perspective view of a suturing device inaccordance with at least some embodiments.

FIG. 4D illustrates a perspective view of a suturing device inaccordance with at least some embodiments.

DETAILED DESCRIPTION

The present invention relates to a method and apparatus for suturing ofsoft tissue at a surgical repair site. In one variation the inventionuses a device that is a combination tissue grasper and suture placementdevice. Although the present invention is described primarily inconjunction with the repair of a torn rotator cuff, the apparatus andmethod could also be used in arthroscopic repair at other sites, such asthe knee, elbow, hip surgery, and for other surgical techniques forsecuring suture in the soft tissues of the body.

One embodiment of a suture passer instrument having a suture capturemechanism is shown in the perspective view of FIG. 1. Suturing device100 includes lower jaw member 102 and upper jaw member 104 disposed at adistal end of the device. Jaws 102 and 104 are connected to an elongatehousing 108 comprising a hollow tube. In certain embodiments, upper jaw104 may be further characterized by opening 105 at the distal end ofdevice 100. Lower jaw 102 may have a suture recess 106 oriented in agenerally perpendicular direction to the longitudinal axis of device 100for engaging and accommodating a length of suture 300 with free ends320, 330 in preparation for stitching the length of suture 300 throughthe soft tissue and subsequently capturing the length of suture 300. Thedistal portion of device 100 between jaws 102, 104 defines a tissuereceiving area 150.

In certain embodiments, upper jaw 104 includes suture capture member 200disposed at the distal end of device 100. Suture capture member 200 mayin some embodiments comprise a suture capture cartridge 201 removablydisposed within opening 105 of upper jaw 104. Referring now to FIGS. 2Aand 3, suture capture member 200 comprises elongate aperture 202 formedby edges 204, 206 on each opposed side. Edges 204, 206 may furthercomprise suture capture surface 208 in certain embodiments. Suturecapture surface 208 may be configured as opposed serrated edges, aplurality of interdigitating teeth, a plurality of opposed notches, orother similar opposed edge features. Suture capture cartridge 200further comprises deflecting portions 210, 212 (i.e., arms 210, 212)which extend from edges 204, 206 respectively, and may be formed in acurved or arcuate shape. Referring now to FIG. 2B, suture capture member200 is disposed relative to upper jaw 104 such that gaps 214, 216 arecreated between arms 210, 212 and the respective inner surfaces withinupper jaw 104. In certain embodiments, cartridge 201 and/or thecomponents of suture capture member 200 are preferably comprised of hightemper spring steel material.

Suturing device 100 is inserted through a trocar cannula until jaws 102,104 reach the tissue to be treated. Upper jaw 104 may be actuated intothe open configuration and soft tissue 400 is introduced into the spacebetween the upper jaw 104 and the lower jaw 102. Referring now to FIG.4A, by means of a mechanism not discussed or shown herein, but of a typewell known to those skilled in the art, the upper jaw 104 is movablerelative to lower jaw 102, causing upper jaw 104 to clamp or grasp thesoft tissue 400 and immobilize it between the upper jaw 104 and thelower jaw 102. In certain embodiments, upper jaw 104 may be pivotedabout a generally perpendicular axis relative to housing 108, oralternatively the connection between lower jaw 102 and upper jaw 104 maybe a reciprocating or cam system wherein upper jaw 104 is movablerelative to lower jaw 102. With upper jaw 104 positioned in proximity tolower jaw 102, jaws 102, 104 are thereby positioned in the closedconfiguration.

In certain embodiments, lower jaw 102 is stationary while upper jaw 104is movable relative to lower jaw 102 or pivotable about a fixed pointcoupled to the distal end of housing 108. The movable nature of upperjaw 104 allows jaws 102, 104 to be actuated between an openconfiguration for receiving tissue and a closed configuration forgrasping tissue. Referring now to FIG. 4B, suture needle 110 is movablydisposed within housing 108, and comprises shaft 112, point 114, andsuture capture area 116. Needle 110 is axially movable within andextendable from housing 108, such that needle point 114 may bepositioned in a retracted position withdrawn from tissue receiving area150 or in an extended position displaced through upper jaw 104.According to the embodiments described herein, needle 110 is configuredsuch that it is generally directable upward from its retracted positionaway from tissue receiving area 150 to its extended position displacedthrough upper jaw 104 and soft tissue 400. For example, it iscontemplated that needle 110 may be ramped generally upward off asurface in lower jaw 102 as it is displaced from the retracted positionto the extended position. In certain embodiments, needle 110 iscomprised of a super-elastic material such as nitinol, has a generallycircular cross-section, and is preformed to include a bend or curvedregion 118 at the distal end portion of needle 110. The super-elasticnature of the material comprising needle 110 in these embodiments allowsthat needle 110 may be disposed in a generally linear configurationwhile placed in the retracted position, and then returns to thepreformed curved configuration during the displacement of needle 110from the retracted to extended position.

The housing 108 is coupled to a handle portion (not shown) having asimilar or the same design as those typically used in conventionalsuturing devices as discussed above. For example, such a handle portionin accordance with the embodiments discussed herein may have astationary grip with a moveable needle deployment lever to actuate axialmovement of the needle. The handle portions further include a deploymentmember or trigger to effectuate closing of the jaws 102, 104 to graspand secure the tissue therebetween.

With the position of the soft tissue 400 grasped between jaws 102, 104and within the tissue receiving area 150 device 100 deemed satisfactory,needle 110 may be deployed by actuation of needle deployment member ortrigger in the handle portion of device 100 to the extended position, asdepicted in FIG. 4B. Needle 110 is advanced axially toward the distalend of device 100 such that suture capture area 116 engages suture 300accommodated in suture recess 106 of lower jaw 102 (as previouslydescribed and depicted in FIG. 1). As described above, in certainembodiments needle 110 comprises a super-elastic material and ispreformed to include a bend or curved region 118. The preformed curvedregion 118 of needle 110 allows that as needle 110 is advanced in agenerally distal direction needle point 114 is urged toward upper jaw104 and needle point 114 thereby penetrates and enters the underside ofsoft tissue 400 grasped between jaws 102, 104. In addition to needlepoint 114 penetrating and entering soft tissue 400, the advancement ofneedle 110 also results in passing suture capture area 116 and thelength of suture 300 engaged within suture capture area 116 through softtissue 400. The tissue receiving area 150 may be defined by protrusionsor teeth 103 to assist in retaining the tissue within the tissuereceiving area 150 as needle 110 advances through the soft tissue 400.

With needle point 114, suture capture area 116, and suture 300 drawnthrough soft tissue 400, the actuation of needle 110 continues untilneedle 110 advances into and through opening 105 in upper jaw 104.Concurrently, needle 110 and length of suture 300 are also directedthrough aperture 202 of suture capture member 200. Referringconcurrently to FIGS. 2B and 4, as needle 110 passes through aperture202, needle 110 contacts edges 204, 206 such that each of arms 210, 212are deflected away from needle 110 and into a portion of gaps 214, 216.The deflection of arms 210, 212 is designed to be elastic such that arms210, 212 respectively return to or spring back into a pre-deflectedposition upon the subsequent withdrawal of needle 110 through aperture202. In the fully extended position of needle 110, the length of suture300 that has been drawn through soft tissue 400 forms a suture portion310 which protrudes from and is disposed above upper jaw 104 and suturecapture member 200. In certain embodiments, suture portion 310 may forma looped configuration.

With the suture portion 310 protruding through suture capture member200, needle 110 may be withdrawn through aperture 202 and returned to aretracted position, as depicted in FIG. 4C. As needle 110 is withdrawnthrough suture capture member 200, arms 210, 212 spring back to anon-deflected position such that aperture 202 and suture capture surface208 are allowed to close around suture portion 310 of suture 300.Aperture 202 is large enough and the spring deflection of arms 210, 212is great enough that these characteristics of suture capture member 200do not restrict the movement of needle 110 during displacement to theextended position. However, arms 210, 212 are configured such that arms210, 212 can only be deflected in an outward direction, away from thetop outer surface of upper jaw 104, as needle 110 is moved throughaperture 202 during displacement to the extended position. In addition,aperture 202 is sufficiently small when arms 210, 212 are in thenon-deflected configuration so that suture portion 310 is not allowed topass back through suture capture member 200. Further, suture capturesurface 208 engages and captures suture portion 310, and further securessuture portion 310 of suture 300 as needle 110 is withdrawn throughaperture 202 and returned to the retracted position. Thereby, sutureportion 310 is trapped in suture capture member 200 on upper jaw 104with a portion of suture 300 simultaneously stitched through soft tissue400. Thereafter, jaws 102, 104 of device 100 are opened to release softtissue 400 from the grasp of device 100.

Referring now to FIG. 4D, with jaws 102, 104 of device 100 fullyactuated into the open configuration and needle 110 displaced to thefully retracted position (not shown), device 100 is pulled away from therepair site and retracted through the trocar cannula, thereby leaving aportion of suture 300 stitched through a portion of soft tissue 400.Concurrently, suture portion 310 of suture 300 may be pulled away fromthe repair site and withdrawn from the trocar cannula. Suture portion310 is manually removed from suture capture member 200 creating suturefree ends 320, 330 that may be utilized to secure soft tissue 400 to adesired location using soft tissue attachment methods or bone anchorsotherwise known in the art.

While preferred embodiments of this invention have been shown anddescribed, modifications thereof can be made by one skilled in the artwithout departing from the scope or teaching herein. The embodimentsdescribed herein are exemplary only and are not limiting. Because manyvarying and different embodiments may be made within the scope of thepresent teachings, including equivalent structures or materialshereafter thought of, and because many modifications may be made in theembodiments herein detailed in accordance with the descriptiverequirements of the law, it is to be understood that the details hereinare to be interpreted as illustrative and not in a limiting sense.

What is claimed is:
 1. A suturing device for use endoscopicallycomprising: a first and second jaw member, the first and second jawmembers being disposed at a distal end of the device; a housing disposedbetween a handle and the first and second jaw members; a needle disposedin the housing while in a retracted position and movable between theretracted position and an extended position, the needle operable toselectively engage a length of suture; and a suture capture memberdisposed on one of the first and second jaw members, wherein the suturecapture member comprises a first and second suture capture surfacedefined by first and second arms respectively, each arm operable to beelastically deflected by the needle when in the extended position, andsuch that a portion of the length of suture is captured between thefirst and second suture capture surfaces upon the needle beingretracted; wherein the first and second arms further define an elongategap between an inner surface of one of the first and second jaw membersand an outer surface of the first and second arm, the first and secondarms being operable to elastically deflect into the elongate gap as theneedle moves to the extended position.
 2. The device of claim 1, whereinthe first and second suture capture surfaces are spaced away from eachother defining an elongate aperture coaxial with a longitudinal axis ofthe suture device.
 3. The device of claim 1, wherein at least one of thesuture capture surfaces comprise a serrated edge.
 4. The device of claim1, further comprising a suture recess disposed proximate the first andsecond jaw members, wherein the suture recess is configured to engagethe length of suture while the needle is in the retracted position. 5.The device of claim 1, wherein extending the needle comprises moving theneedle axially in a distal direction.
 6. The device of claim 1, whereinthe first and second arms comprise a distally disposed channel thatengages a distal end of one of the first and second jaw members, thechannel further defining the elongate gap.
 7. The device of claim 1,wherein the suture capture member comprises a suture capture cartridgeremovably disposed on one of the first and second jaw members.
 8. Amethod of placing a suture in soft tissue comprising; placing the softtissue between a first and second jaw member, the jaw members coupled toan elongate housing; moving a needle so as to selectively engage alength of suture disposed adjacent the first jaw member; advancing theneedle and length of suture so as to penetrate the soft tissue andextend into and through an opening associated with the second jawmember, wherein a first and second arm extend from the opening defininga first and second arm outer surface and wherein at least a portion ofboth arm outer surfaces are spaced away from a corresponding first andsecond inner surface of the second jaw member defining a first andsecond elongate gap, and wherein the step of advancing the needle,deflects both arms so that the at least a portion of both arm outersurfaces move into a portion of the corresponding elongate gap.
 9. Themethod of placing a suture of claim 8 wherein the opening forms anelongate aperture, coaxial with a longitudinal axis of the elongatehousing.
 10. The method of placing a suture of claim 8 furthercomprising the step of retracting the needle and leaving at least aportion of the suture secured within the opening.
 11. The method ofplacing a suture of claim 10 wherein the opening comprises at least oneserrated edge configured to assist in securing the portion of suture asthe needle is retracted.
 12. A method of placing a suture in soft tissuecomprising; placing the soft tissue between a first and second jawmember, the jaw members coupled to an elongate housing; moving at leastone of the jaw members so as to grasp the soft tissue; moving a needleso as to selectively engage a length of suture disposed adjacent thefirst jaw member; advancing the needle so as to penetrate the softtissue and engage a first and second suture capture surface associatedwith the second jaw member and move a first suture capture surface,wherein a first arm extends from the first suture capture surface, thefirst arm having a first arm outer surface and wherein at least aportion of the first arm outer surface is spaced away from a first innersurface of the second jaw member defining a first elongate gap, andwherein the step of advancing the needle, deflects the first arm so thatthe at least a portion of the first arm outer surface moves into thefirst elongate gap.
 13. The method of placing a suture of claim 12,wherein the step of advancing the needle so as to penetrate the softtissue also moves the second suture capture surface, the second suturecapture surface extending from a second arm and comprising a second armouter surface, wherein at least a portion of the second arm outersurface is spaced away from a second inner surface of the second jawmember defining a second elongate gap, and wherein the step of advancingthe needle moves the second suture capture surface and deflects thesecond arm so that the at least a portion of the second outer surfacemoves into the second elongate gap.
 14. The method of placing a sutureof claim 13 wherein the first and second capture surfaces are spacedaway from each other to form an elongate aperture, coaxial with alongitudinal axis of the elongate housing.
 15. The method of placing asuture of claim 12 further comprising the step of retracting the needlewhile leaving at least a portion of the length of suture between thefirst and second suture capture surface.
 16. The method of placing asuture of claim 15 wherein the step of retracting moves the firstsurface away from the first inner surface of the second jaw member. 17.The method of placing a suture of claim 15 wherein the first suturecapture surface comprises a serrated edge configured to assist insecuring the portion of the length of suture as the needle is retracted.18. The method of placing a suture of claim 14 wherein the aperturecomprises at least one serrated edge configured to assist in securingthe portion of suture.
 19. The method of claim 12 wherein the needlecomprises a preformed curved region that is elastically bent so as tobecome generally linear while disposed in the housing and wherein theneedle returns to comprise the preformed curved region during theadvancing step.